Public Citizen Says 80 mg Zocor Should be Recalled

The influential consumer group Public Citizen is criticizing the U.S. Food & Drug Administration (FDA) for its recent decision to restrict us of the 80 mg <"">Zocor (simvastatin). On its “Worst Pills, Best Pills” Website, Public Citizen said the highest dose of Zocor and its generic equivalents should be recalled due to its association with a risk of serious and potentially life-threatening muscle damage called myopathy.

Muscle aches are a well-known side effect of Zocor and other drugs in the same class, known as statins, and the labels for the class already bear warnings regarding this risk. The most serious form of myopathy, called <"">rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal, the agency said.

In 2010, the FDA issued a safety alert for high-dose simvastatin because of its association with myopathy. Then last week, the FDA told doctors not to prescribed 80 mg Zocor and simvastatin to patients in their first 12 months of treatment. According to the agency, the Zocor 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury. The FDA also said health care professionals should switch such patients to another statin if they find that taking 40 mg of simvastatin isn’t meeting their LDL cholesterol goal, rather than raising the simvastatin dose to 80 mg.

The FDA’s new recommendation was prompted by a seven-year study and patient reports that prove those taking the higher dosage of simvastatin have a greater risk of muscle injury than patients treated with lower doses or other statins. The new restrictions and warnings also apply to Vytorin and Simcor, which are combination medications that include simvastatin as an active ingredient. Generic versions of simvastatin will also include the myopathy warnings and be subject to dosing restrictions.

According to The Los Angeles Times, Public Citizen doesn’t think the FDA went far enough.

“We believe that the 80-milligram dose should be taken off the market completely,” says Dr. Michael Carome, deputy director of the Health Research Group for Public Citizen, said. He noted that the higher doses don’t seem to be much more effective than lower doses, but pose a greater risk.

In a statement on its “Worst Pills, Best Pills” Website, Public Citizens placed high-dose Zocor on its “Do Not Use” list. The group urged all consumers taking the 80 mg version to speak with their doctors about switching to another medication or lower Zocor dosage, even if they have not experienced any issues.

Symptoms of myopathy include weakness, muscle pain or tenderness, and fatigue. If the myopathy progresses to rhabdomyolysis, it can cause dark or red-colored urine. Anyone taking Zocor or another simvastatin product should contact their doctor immediately if they experience any of these symptoms, regardless of dosage.

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